Medicament carriers comprising a ribbing and methods of using same

ABSTRACT

A blister pack may include a first layer, a second layer and a third layer. The first layer may include a hole. The second layer may include an indentation substantially aligned through the hole when the first and second layers are aligned and a second area surrounding the indentation. The third layer, which is in contact with the second layer, may include a third area that is substantially aligned with the second area when the second and third layers are aligned. The indentation may contain a medicament. The blister pack may include adhesives that secure the second layer to the first layer and the third layer. The second and third areas may be scored, cut and/or perforated. When sufficient force is applied to the third area, a blister, including the second and third areas, may be displaced containing the medicament.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a divisional of, and incorporates byreference in its entirety, U.S. patent application Ser. No. 11/336,295entitled “Medicament Carriers And Methods Of Using Same” and filed Mar.2, 2006, which is a continuation-in-part of, and incorporates byreference in its entirety, U.S. patent application Ser. No. 11/013,010entitled “Universal Medication Carrier” and filed Dec. 15, 2004, whichclaims priority to, and incorporates by reference in its entirety, U.S.Provisional Patent Application No. 60/565,220 filed Apr. 24, 2004.

FIELD OF THE INVENTION

The disclosed embodiments generally relate to the fields of medicamentstorage and dispensing.

BACKGROUND OF THE INVENTION

In conventional medicament dispensing systems, prescriptions aretypically filled in either thirty-day or sixty-day allotments. With suchsystems, there is no accurate way to inventory medicaments, to auditpatient compliance with a pharmacist's or physician's instructions,and/or to audit administration of the medicament. This is due in partbecause medicaments are dispensed in a lot, and not every pill or doseis separately bar coded and/or otherwise traceable.

Medicaments can be supplied in a foil- or paper-wrapped blister packcontaining a plurality of individual unit doses. A number of deviceshave been developed to assist physicians, pharmacists, nurses or othermedical personnel in administering unit doses contained in a standardblister pack. U.S. Pat. No. 5,489,025 to Romick and U.S. Pat. No.6,540,081 to Balz et al. are examples of such devices. Romick disclosesa medication dispenser having a top plate with at least one aperture forreceiving the blister portion of a blister pack, a bottom plate adaptedto engage the top plate so as to confine the blister pack between theplates and having at least one aperture in register with the blisterportion, and a bridge spanning the top plate and supported by supportmembers. Balz et al. discloses a dispenser for dispensing a unit dose ofa solid product contained in a blister pack. The dispenser includes ahousing, a back plate, and a dispensing tray. The blister packcontaining product is positioned between the housing and the back plate,whereby the product is dispensed through the back plate into thedispensing tray where it can be acquired for use. A puncture tab isintegrated into the back plate to assist in rupturing the backing of theblister pack when dispensing the product.

Although these devices decrease the likelihood of errors in theadministration of medication in a health care facility by preventing theunit doses from being removed from the blister portion of the blisterpack until the foil backing is ruptured, the subject devices suffer froma number of limitations. Primarily, the devices are not intended forholding a plurality of different medications and/or varying dosagesprescribed as part of a complex treatment regimen. In conventionalblister pack holders, medicaments are organized according to theirrespective times of administration. As such, the existing blister packholders are limited in their ability to provide the flexible dosageadministration that is required for situations where the patient'sregimen is the subject of frequent dosage adjustments or the patient isprescribed more than one medication to be administered at varying timesover the course of a day or over the course of several weeks or months.

Moreover, conventional devices are not suited for use by a patient in ahome, assisted living facility, or other setting remote from the supportof health care professionals. As described above, conventional blisterpack holders organize medicaments according to their respective times ofadministration. However, they fail to provide a mechanism by which theadministration of a prescribed medication or dosage can be remotelyadjusted in real-time, in response to an unexpected change in apatient's health condition. A delay of several hours to several days canoften result before a patient is enabled to administer a new dosage ormedicament. During this period, the patient may be confused as to thecorrect dosing regimen and continue to take doses according to thepredetermined sequence provided in the blister pack. In addition,because a new prescription and allotment of blister packs is requiredevery time a dose is adjusted, the patient must travel to a physician'soffice and pharmacy. This is particularly disadvantageous formobility-impaired patients and is a major source of drug noncompliance.Frequently, the patient's condition deteriorates because the patient isunable to continue his course of treatment.

An additional shortcoming of conventional medication holders is thatthey are relatively complicated, requiring manufacture and assembly ofvarious moveable parts. A still further shortcoming of conventionalcontainers and storage devices is that they do not provide a practicalmeans of quickly inventorying the exact amount of medication remainingin a prescription, and the amount of medication consumed by a patient.

Accordingly, what is needed is a convenient device for storing one ormore types of medicaments.

A need exists for a device that permits inventorying of medicamentswithin a dispensing unit.

A need exists for a device that dispenses a dose of a medicament in anindividual package.

A need exists for a device that dispenses a dose of a medicament in anindividual package including information pertaining to the containedmedicament.

A further need exists for a method of dispensing medicaments to patientsin a manner that includes a prescribed treatment regimen.

The present disclosure is directed to solving one or more of theabove-listed problems.

SUMMARY OF THE INVENTION

Before the present methods, systems and materials are described, it isto be understood that this disclosure is not limited to the particularmethodologies, systems and materials described, as these may vary. It isalso to be understood that the terminology used in the description isfor the purpose of describing the particular versions or embodimentsonly, and is not intended to limit the scope.

It must also be noted that as used herein and in the appended claims,the singular forms “a,” “an,” and “the” include plural references unlessthe context clearly dictates otherwise. Thus, for example, reference toa “medicament” is a reference to one or more medicaments and equivalentsthereof known to those skilled in the art, and so forth. Unless definedotherwise, all technical and scientific terms used herein have the samemeanings as commonly understood by one of ordinary skill in the art.Although any methods, materials, and devices similar or equivalent tothose described herein can be used in the practice or testing ofembodiments, the preferred methods, materials, and devices are nowdescribed. All publications mentioned herein are incorporated byreference. Nothing herein is to be construed as an admission that theembodiments described herein are not entitled to antedate suchdisclosure by virtue of prior invention.

In an embodiment, a blister pack may include a first layer, a secondlayer and a third layer. The first layer may include a hole. The secondlayer may include an indentation that is substantially aligned throughthe hole when the first layer is aligned with the second layer. Theindentation may contain a medicament. The second layer may include asecond area surrounding the indentation. The third layer may be incontact with the second layer and may include a third area that issubstantially aligned with the second area when the second layer isaligned with the third layer. The second area and the third area mayeach include one or more of a scoring, a cutting and a perforation. Whensufficient force is applied to the third area, the second area and thirdarea may be displaced from the blister pack to form a blister containingthe medicament.

In an embodiment, a method of assembling a blister pack may includeplacing a first layer, having a hole, in a loading tray of a loadingstation, placing a second layer, having an indentation that issubstantially aligned with the hole when the second layer is placed,placing a medicament in the indentation, placing a third layer on thesecond layer, and compressing the first layer, the second layer and thethird layer in a heat press.

In an embodiment, a method of removing a medicament from a blister packmay include selecting a first blister containing a medicament from oneor more blisters in a blister pack, applying force to a first side ofthe first blister to dislodge the first blister from the blister pack,and removing the medicament from the first blister.

In an embodiment, a blister pack may include a ribbing comprising aplurality of blisters, whereby when sufficient force is applied to ablister, the blister is displaced from the ribbing, whereby when one ormore blisters have been displaced, the ribbing provides substantiallyequivalent support to any remaining blisters as the ribbing providedprior to such displacement.

BRIEF DESCRIPTION OF THE DRAWINGS

Aspects, features, benefits and advantages of the embodiments describedherein will be apparent with regard to the following description,appended claims and accompanying drawings where:

FIGS. 1A-1 C depict exemplary layers of a blister pack according to anembodiment.

FIG. 1D depicts an alternate exemplary first layer of a blister packaccording to an embodiment.

FIG. 2 depicts an exemplary backing sheet for a blister pack accordingto an embodiment.

FIG. 3 depicts a flow diagram for an exemplary method of assembling ablister pack according to an embodiment.

FIG. 4 depicts a flow diagram for an exemplary method of administering amedicament according to an embodiment.

DETAILED DESCRIPTION OF THE PRESENT EMBODIMENTS

As used herein, a “medicament” may include one or more of an individual,unit-of-issue dose of prescription and/or non-prescription medications,medical supplies, pharmaceuticals, nutraceuticals, injectibles, medicaldevices, diagnostic materials and other therapeutic products. Amedicament may, where applicable, be in liquid, solid or gaseous form.Specific examples of medicaments may include, without limitation,suppositories, pre-filled syringes, inhalers, lotions, suspensions,blood testing strips, pills, tablets and caplets.

FIGS. 1A-1C depict exemplary layers of a blister pack according to anembodiment. As shown in FIG. 1, a blister pack 100 may include a firstlayer 105 (shown in FIG. 1 A), a second layer 11 0 (shown in FIG. 1 B)and a third layer 11 5 (shown in FIG. 1 C). The first layer 105 of theblister pack 100 may include a bottom board. The bottom board may haveone or more holes, such as 120. In an embodiment, a first area 125 maysurround a hole 120. In an alternate embodiment, shown in FIG. ID, nofirst area may be present surrounding a hole 120. In an embodiment, anadhesive may be applied to the first layer 105. In an embodiment, thefirst layer 105 may include, for example, cardboard and/or a plastic.

A second layer 110 may include a plastic or PVC material with one ormore indentations, such as 130. Each indentation 130 may be placed suchthat the indentation aligns with a corresponding hole of the bottomboard when the second layer 110 and the bottom board are aligned foruse. The number and size of the one or more indentations 130 may varybased on the number and size of one or more medicaments to be containedwithin the blister pack 100.

Each of the first layer 105 and the second layer 110 may be scored, cutand/or perforated to enable an individual unit dose (a “blister”) to beremoved from the blister pack 100.

A third layer 115 may include, for example, a foil sheet with anadhesive. When the adhesive of the third layer 115 and the adhesive ofthe first layer 105 are heated and then cooled, each of the third layerand the first layer may become adhered to the second layer.

The foil sheet may be attached to a backing sheet. The foil sheet and/orthe backing sheet may be scored, cut and/or perforated to match thescoring, cutting and/or perforation of the first layer 105 and thesecond layer 110 when the blister pack 100 is properly aligned. Thescoring, cutting and/or perforation of the layers may ease removal of anindividual unit dose from the blister pack.

In an embodiment, the third layer 115 may comprise a foil sheet, a papersheet and a cardboard sheet. Each sheet may be may be scored, cut and/orperforated. The foil sheet may enable the third layer to be contacted bya heat press during assembly of a blister pack. The cardboard, or asimilar material, may be used to stiffen the third layer to enable ablister to be properly removed from a blister pack (as described in moredetail below). Additional or alternate materials may also be used withinthe scope of this disclosure as will be apparent to one of ordinaryskill in the art.

In an embodiment, a blister pack may be assembled using a loadingstation. A loading station may include a loading tray. The loading traymay include a plurality of spring-loaded pegs and/or pins, which becomesubstantially flush with the loading tray when compressive force isapplied to a blister pack 100. In an embodiment, the amount of force toapply to a blister pack 100 during assembly may be determinable based onthe amount of compression of the spring-loaded pegs and/or pins.

Each layer of a blister pack 100 may include one or more guide holes150, for example, on its outer perimeter. Each guide hole 150 may alignwith a corresponding loading tray guide peg and/or pin. The guide holes150 may also be used to assist in alignment of a blister pack 100 whenloaded into a medicament dispensing unit (“MDU”).

FIG. 2 depicts an exemplary backing sheet for a blister pack accordingto an embodiment. The blister pack may include, for example, a barcode205 and/or information 210 identifying the blister pack and/oridentifying a medicament. The barcode 205 and/or information 210 may beprinted on, for example, the backing sheet or a label attached to thebacking sheet. In an embodiment, if the barcode 205 and/or otherinformation 210 identifies a medicament, the barcode and/or otherinformation may be printed and/or placed on the backing sheet proximateto the location at which the medicament is located within the blisterpack.

A barcode 205 may include any electronically scannable and/or readableindicia, such as a barcode, an RFID tag, and/or any other marking thatmay be scanned and/or read by a device. The barcode 205 may be scannedor read using an electronic scanner, such as a barcode scanner, anoptical recognition scanner or a radio frequency identification (“RFID”)scanner. In an embodiment, the barcode 205 may uniquely describe theblister pack. In an embodiment, the barcode 205 may include one or moresegments pertaining to features of the blister pack and/or the one ormore medicaments contained therein. For example, a first barcode segmentmay pertain to a layout format for the blister pack, a second barcodesegment may pertain to an item number pertaining to at least onemedicament in the blister pack, and a third barcode segment may pertainto a unique serial number for each item number. In an embodiment, ifmore than one type of medicament is included in a single blister pack,at least a segment of the barcode 205 may be used to determine where amedicament of a particular type is located in the blister pack.

The medicament information 210 may include, for example and withoutlimitation, a lot number of the medicament, an expiration date of themedicament, a name of the medicament, a dosage pertaining to themedicament and/or a patient name. In an embodiment, the medicamentinformation 210 may include any information that identifies themedicament and/or its usage after being removed from the blister pack.

In an embodiment, the barcode 205 and/or the medicament information 210may be printed and/or placed such that when a blister containing themedicament is displaced from the blister pack, the barcode and/ormedicament information may be on the blister. In an embodiment, thebarcode 205 and/or the medicament information 210 may be printed and/orplaced such that when a blister containing the medicament is displacedfrom the blister pack, the barcode and/or medicament information mayremain on the blister pack. In an embodiment, if different medicamentsand/or different doses of the same medicament are included in a singleblister pack, a barcode 205 and/or the medicament information 210 may beprinted and/or placed such that the blister containing the medicament islabeled to identify the medicament and/or dosage of the medicament whenthe blister is removed from the blister pack.

Unique identifiers may be placed and/or printed on the backing sheet toprovide a key for proper orientation of the blister pack 100 wheninserted into an MDU. In an embodiment, a first identifier 215 may beplaced on a first side of the blister pack 100 and a second identifier220 may be placed on a second side of the blister pack 100. The firstidentifier 215 and the second identifier 220 may each be replicated oneor more times on a side of the blister pack 100. In an embodiment, whena blister pack 100 is inserted in an MDU, the MDU may scan one or moreof the first identifier 215 and the second identifier 220 to determineif the blister pack is inserted in the correct orientation. In anembodiment, each of the first identifier 215 and the second identifier210 may comprise a bar code, an RFID tag, a scannable image, scannabletext, and/or the like.

In an embodiment, a different portion of the blister pack 100, such asthe first layer 105, may include one or more of a barcode and anidentifying label. In an embodiment, additional or alternate informationmay be printed on the blister pack 100 within the scope of thisdisclosure.

FIG. 3 depicts a flow diagram for an exemplary method of assembling ablister pack according to an embodiment. A first layer may be placed 305in a loading tray. In an embodiment, an adhesive may be applied to thefirst layer while in the loading tray or prior to placing the firstlayer in the loading tray.

The second layer may be placed 310 on the first layer with theindentations facing down. Each of the first layer and the second layermay be aligned using one or more guide pins of the loading tray. In anembodiment, an adhesive may be applied to one or more of the upper andlower surface of the second layer 310 prior to placement in the loadingtray. In an embodiment, an adhesive may be applied to the upper surfaceof the second layer 310 after placement in the loading tray.

In an embodiment, one or more indentations may be flood-filled 315 withmedicaments according to standard pharmacy practices using conventionalpharmacy devices for loading blister packs. Other methods of filling oneor more indentations may also be performed within the scope of thepresent disclosure.

The third layer may have one or more bar codes and identifying labelsprinted and/or placed 320 on, for example, its backing sheet. In anembodiment, one or more of the bar codes and identifying labels may beprinted and/or placed on the third layer prior to the third layer beingplaced on the second layer. In an embodiment, the printing or placementof one or more bar codes or identifying labels may be performed afterthe third layer is placed on the second layer.

When each appropriate indentation is filled, a third layer may be placed325 on top of the second layer. The third layer may be aligned using theguide pins on the loading tray during placement. An adhesive may beapplied to the lower surface of the third layer prior to placement inthe loading tray.

The loading tray may then be placed 330 in a heat press. Force may beapplied 335 to the loading tray, and one or more guide pins may becompressed to a position level with the blister pack to ensure acomplete seal of the blister pack.

FIG. 4 depicts a flow diagram for an exemplary method of administering amedicament according to an embodiment. As shown in FIG. 4, when amedicament is to be administered or delivered, the desired dose(“blister”) may be determined 405 from, for example, the identifyinglabel on the blister card. Force may be applied 410 to a portion of thethird layer corresponding to the blister in order to dislodge theblister from the blister pack. A blister may be dislodged 410 manuallyor by a MDU. The medicament may then be removed 415 from the blister byapplying force to an indentation of the blister. The removed medicamentmay then be administered 420.

In an embodiment, the blister pack may be suited for blisteradministration by a patient in, for example, a home, assisted livingfacility, or other non-clinical setting via a distribution device. In analternate embodiment, the blister pack may be used in a hospital,clinic, long-term care facility or other location in which medicalpersonnel are typically present. In such clinical environments, theblister pack may be stored until the patient's scheduled dosing time. Atthe designated dosing time, a healthcare practitioner may inspect theblister pack label and scan the barcode to acknowledge theadministration of the medicament. The practitioner may extract 410 thesealed blister from the blister pack by applying force to the thirdlayer of the blister pack on the desired blister.

The blister pack may also serve as a medication management andcompliance tool by ensuring accurate delivery of both custom packagedand commercially available sealed unit dose and unit-of-issuetherapeutic products to a patient. The blister pack may fostercompliance with a prescribed treatment regimen by, for example, ensuringthat the patient remains within recommended therapeutic levels. If thehealth of a patient changes or a dosing change is required, a healthcarepractitioner may adjust the prescribed dosage in real-time without theneed for a new prescription. The healthcare practitioner may achievethis by reviewing the stored inventory record of medicaments within thepatient's blister pack and directing the patient to take a differentmedication or dosage having a higher or lower strength, as appropriate.

The design of the blister pack may enable medicaments to be administeredto a patient in a non-consecutive order, without any serial deliveryrestrictions. As such, a remotely located practitioner may make dosingchanges without any disruption to the patient's course of treatment viaa MDU.

Unlike conventional blister packs, individual blisters may be ejectedfrom the blister pack, and each blister may remain sealed in a unit doseafter ejection. This may permit a user to eject a medicament from theblister pack for later use (allowing the patient to be separated fromthe blister pack at the time of medicament administration).

In an embodiment, a blister pack may include one or more blisterssurrounded by a ribbing. The ribbing may provide support to all blisterswhen force is applied to a blister. In other words, as a blister isdisplaced, the ribbing may support the area surrounding the blister thatis being displaced and the remaining blisters so that the blister thatis being displaced may be properly displaced. After one or more blistershave been displaced, the ribbing may still provide substantiallyequivalent support to the remaining blisters to permit displacement ofthe remaining blisters from the blister pack in the future. In anembodiment, the ribbing may surround each blister prior to the blisterbeing displaced from the blister pack. In an embodiment, the ribbing mayremain when all blisters have been displaced from the blister pack.

Conventional medication dispensing systems dispense medicaments in alot. In other words, such systems do not separately encode each pill ordose. As such, the doses are not traceable. In an embodiment, individualblisters may be labeled to denote the medicament contained therein.Thus, delivery and administration of medicaments may occur on a unitdosage basis in which each dose is inventoried with its ownelectronically coded identifier. This may enable a healthcarepractitioner to accurately monitor patient compliance with a prescribedtreatment regimen from a remote location.

The blister pack may be of a standard pharmacy size and may be filleddirectly by standard pharmacy tools known to those of ordinary skill inthe art. For example, the blister card may be about 9 inches by about 6inches. The blister card may include one or more guide holes on one ormore sides. The guide holes may be used to align the blister card in aloading tray of a loading station. The blister card may further includeone or more blisters as described above.

It will be appreciated that various of the above-disclosed and otherfeatures and functions, or alternatives thereof, may be desirablycombined into many other different systems or applications. Also thatvarious presently unforeseen or unanticipated alternatives,modifications, variations or improvements therein may be subsequentlymade by those skilled in the art which are also intended to beencompassed by the following claims.

1. A blister pack, comprising: a ribbing comprising a plurality ofblisters; whereby when sufficient force is applied to a blister, theblister is displaced from the ribbing; whereby when one or more blistershave been displaced, the ribbing provides substantially equivalentsupport to any remaining blisters as the ribbing provided prior to suchdisplacement.
 2. The blister pack of claim 1 wherein the ribbingsurrounds each blister before a blister is displaced.